📍 Gurugram, HR, India
About the job Regulatory Affairs Specialist-II
A Day in the Life Manage, plan and execute the preparation, review and submission of dossiers for product registrations, import licenses and other approvals from regulatory agencies (registrations and renewals) thereby supporting the business units and supply chain management in compliance with regulatory requirements in India. Coordination with global regulatory teams, local BU other functions, for regulatory strategies and all documentation support required for regulatory submissions in India. Submit and track registration/re-registration applications with the authorities. Liaise with product divisions and obtain relevant details for filing changes to the approved products/licenses. Assess the Change controls from the product divisions through post approval change management and continuously ensure regulatory compliance (reporting of adverse events/field actions, etc.). Understanding interpretation of law the local regulatory requirement and implementing same in submission with compliance. Close monitoring of any changes in local global regulations and communicating same within the department and respecting following all SOP / system implemented within the department and organization. Ensure business continuity through regulatory filings, obtaining regulatory approvals and continuously ensuring regulatory compliance. Also ensure continuous implementation of the Quality Management System in India. Supporting the Marketing Teams on Tender related issues Development, implementation and maintenance of regulatory systems pertaining to regulatory document management (SOP’s, archival, trackers and systems) within the department and organization. Interface and coordinate with regulatory agencies/competent authorities (CDSCO, CDDA, DGDA, State FDA, DoT, AERB, etc.) with respect to submissions, obtaining registrations/licenses, amendments, regulatory compliance, packaging, quality control testing or release, etc. Work with clinical team on submission and approval of clinical trials applications (clinical trial approvals, import licenses/test licenses for clinical trial, amendments, etc.) from various regulatory agencies in the India.
Must Have: Minimum Requirements
- B Pharm / M Pharm / Bachelor or Master Degree in Bio-Medical Engineering / Science discipline with training in Regulatory Affairs
- Must have at least 5-7 years experience in the pharma/medical device/life science industry with at least 2-3 years’ medical device experience in regulatory affairs
- Conversant with various regulatory requirements for India with respect to medical device registration, import, clinical trials, etc.
- Knowledge in application of CDSCO, FDA, CE and other regulatory requirements especially in the area of Quality Systems and Design Control as applied to projects from design inception to manufacturing release
- Excellent communication and interpersonal skills – Good verbal communicator and presenter
- Customer focused: Understands and delivers customer service
- Ability to quickly establish credibility with all levels of Regulatory Agencies, Government, etc.
- Good verbal and written communication skills in English – with colleagues, management and external authorities
- Self-motivated and positive “Can do” attitude. Can work autonomously but is also a team player
- Outgoing and friendly: Enthusiastic, energetic, diplomatic, willingness to learn
- Be able to plan, manage, organize and report in an efficient way
- Be independent, persuasive, innovative and able to summarize
- Good time management: Well organized, able to set and reset priorities
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